Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	LDH Level at Week 27 (Parallel Comparison)	Week 27	The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).
Primary	Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)	From Week 13 to Week 27, from Week 39 to Week 53, and from Week 65 to Week 79	The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.
Secondary	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Total complement (%) was measured in serum using an assay method and compared the total hemolytic complement activity to the lower limit of the normal human reference (LLN) of 58 U/mL for all CH50 values. The percent of LLN of CH50 at each time point was calculated as mean CH50 results/LLN x 100%. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Mean Total Hemoglobin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Mean Serum-free Hemoglobin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Mean Haptoglobin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Mean Bilirubin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Degree of Hemoglobinuria	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	The degree of hemoglobinuria was categorized as negative, trace, small, moderate, and large based on the analysis of urine samples collected from each participant at the specified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Mean Percentage of Type III Erythrocytes	Baseline, Week 27, Week 39, Week 53, Week 65 and Week 79	As a measure of hemolysis the mean percentage of Type III erythrocytes was measured at the specified timepoints. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	LDH Levels at Week 53 and Week 79	Week 53 (first week of Period 2) and Week 79 (last week of Period 2)	The analysis of the crossover comparison of hemolysis, as measured by LDH at Week 53 and Week 79.
Secondary	Mean LDH Levels by Visit up to Week 79	Baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 25, Week 27, Week 29, Week 33, Week 39, Week 41, Week 43, Week 45, Week 47, Week 49, Week 51, Week 53, Week 55, Week 59, Week 65, Week 67, Week 69, Week 71, Week 73, Week 75, Week 77, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Mean Number of Packed RBC Units Transfused Per Month	Baseline to End of Study (up to Week 79)	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)	PK samples were collected predose and immediately postdose Week 13, 7 days post the Week 13 dose (Week 14), and predose at Week 15	The total and unbound PK concentration AUC values from Week 13 to Week 15 in Period 1 are presented by actual treatment received.
Secondary	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	PK samples were collected predose at the prespecified timepoints: baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77, and Week 79	The total and unbound serum trough concentrations are presented by treatment sequence received for the prespecified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Day 1 to End of Study (up to Week 79)	TEAEs are defined as any adverse event (AE) that began or increased in severity or frequency at or after the time of first treatment up to end of study (up to Week 79). A treatment-emergent serious adverse event (SAE) was a TEAE that met at least 1 of the following criteria: was fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another medically important serious event. The treatment-emergent events of interest (EOI) prespecified for this study included serious infections (meningococcus aspergillus, and other serious infections/sepsis), and infusion reactions.
Secondary	Number of Participants With Antidrug Antibodies (ADAs)	Blood samples for ADA assessments were taken predose at baseline, Week 3, Week 7, Week 13, Week 19, Week 25, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77 and Week 79.	Any samples that tested positive for binding antibodies were also tested for neutralizing antibodies. Treatment boosted ADAs were defined as a positive immunoassay result at baseline and at least 1 postbaseline immunoassay result that was ≥ 4 times the magnitude of the baseline result. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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